Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

An intervention to stop tobacco use among patients suspected of tuberculosis (TB): an evaluation of an integrated approach

Acronym

TATO

Study hypothesis

1. What is the effect of an intervention, based on the World Health Organization (WHO) 'five steps to quit' model and consisting of training of health professionals, a desk-guide, a desktop patient education tool and leaflet, on patients' point and continuous abstinence from tobacco use? [Effect evaluation] 2. To what extent do the health professionals communicate risks of tobacco use and benefits of its cessation to their patients? What are their experiences and opinions about this strategy? [Process evaluation] 3. How do patients experience the intervention for tobacco addiction? [Ethical evaluation] 4. What is the incremental cost-effectiveness ratio of the intervention for tobacco addiction compared to usual care? [Economic evaluation]

Ethics approval

Research Ethics Committees of TB programme and Pakistan Medical Research Council, approval pending as of 05/12/2008.

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tuberculosis and tobacco use

Intervention

A total of 22 primary care health centres will be selected (11 each for control and intervention arms) and 50 patients recruited with suspected tuberculosis in each of these centres.

In the intervention arm, recruited patients will be given the 'five steps to quit' model. This is based on the evidence-based recommendations for treatment of tobacco addiction published by WHO in 2001. Participants will be: 1. Asked about the status of nicotine use2. Advised about the benefits of stopping nicotine use3. Assessed for their motivation to stop its use4. Assisted in stop attempts through various therapeutic options5. Provided with an information leaflet 6. Asked to arrange a follow-up

In the control arm, patients will be provided with education leaflets only.

The trial will continue for six months and a review at 1 and 6 months will take place to assess smoking status and clinical outcomes in both arms.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Point abstinence at 4 weeks: the proportion of trial participants who have completely given up all forms of nicotine use at four weeks after the completion of NRT, bupropion and/or brief counselling therapy2. Continuous abstinence up to 6 months: proportion of trial participants who remained abstinent from 4 weeks onwards up to six months3. We will also measure tobacco use, e.g. number of cigarettes smoked per day to estimate any reduction in tobacco use secondary to the intervention

Secondary outcome measures

1. Incidence of various adverse affects secondary to therapy2. Economic outcomes assessed in terms of healthcare cost to get one person to stop smoking at four weeks. Healthcare cost will include the treatment cost, the average duration of health professionals' time spent with the patients during assessment, advice and counselling.3. Process outcomes include: 3.1. The proportion of tobacco users who decide to quit and registered to receive 'five steps to quit' intervention3.2. The proportion of people registered who continue follow-up for the full period planned

Overall trial start date

01/12/2008

Overall trial end date

30/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

In each health centre, we will approach adult patients (greater than or equal to 18 years, either sex), who cough for three or more weeks and are therefore suspected and screened for pulmonary tuberculosis.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1100

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/12/2008

Recruitment end date

30/11/2011

Locations

Countries of recruitment

Pakistan

Trial participating centre

Nuffield Centre for International Health and Development
Leeds
LS2 9LJ
United Kingdom